开题报告内容：（包括拟研究或解决的问题、采用的研究手段及文献综述，不少于2000字）
Good quality must be built in during the manufacturing process; it cant be tested into the product after wards. In process check is one tool guarantee the product quality during manufacturing process. This tool minimizes the risks involved in any pharmaceutical production that can not be eliminated through testing the final product.
Good manufacturing practice(GMP) is a system for ensuring that products are consistently manufactured and controlled according to quality standards. GMP covers all aspects of production, from the starting materials premises, equipment, training, personal hygiene of staff to distribution of finished product.
Written production and process control procedures shall be designed to assure that drug products meet identity, strength, safety, purity and quality requirements.
IPQA personnel must be vigilant and sharp enough to check and verify the system compliance. He should have a hawk eye to identify the non conformances.
The following is the requirement for production and process controls as per code of federal regulations part 211:
211.100 Written procedures;deviations
(a) There shall be written produces for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represent to possess. These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit.
(b) Written production and process control procedures shall be followed in the execution of the various production and process control functions and shall be documented at the time of performance. Any deviation from the written procedures shall be recorded and justified.
211.101 Charge-in of components
以上是毕业论文文献综述，课题毕业论文、任务书、外文翻译、程序设计、图纸设计等资料可联系客服协助查找。
